MAUDE Adverse Event Report: SYNCLARA, NON-FT SW,HC,NA; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Model Number M08575

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pleural Effusion (2010); Pneumothorax (2012)

Event Date 01/21/2022

Event Type  Injury  

Event Description

The customer initially reported after initial training on the synclara device, he used the device for 3 days and then started coughing up blood and was diagnosed with a collapsed lung.The device was located at the patients home.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The customer initially reported after initial training on the synclara device, he used the device for 3 days and then started coughing up blood and was diagnosed with a collapsed lung.The patient stated he was hospitalized for six days and had a chest x-ray and ct scan.A chest tube was placed for what he thought was a pleural effusion.The patient believes this happened due to using the synclara device.The patient declined a trainer visit and requested to have the device picked up.The following additional information was obtained from the patient: the patient stated he used the synclara device for 3 days and started coughing up blood and experienced difficulty breathing.The patient's wife drove him to the emergency room, and he was hospitalized for 7 days for a collapsed lung.The patient stated his physician mentioned a pneumothorax and/or pleural effusion.The patient stated he had air and fluid between his chest and lung and a chest tube was placed.The patient stated he is currently taking prednisone (which he occasionally takes) and is using an inhaler.The patient stated he has a follow up appointment with his pulmonologist next week.The patient¿s physicians stated the event could have been caused by the device or the patient may have had a sac that was getting ready to burst, they just did not know.The patient stated there was nothing wrong with the device and he did not allege a device malfunction.Patient's medical history includes bronchiectasis.The patient denies any other medical history.The patient reiterated he thought he and his physician discussed vest therapy and stated he can cough just fine and does not need device assistance with this.However, it was confirmed with the hillrom respiratory clinician that the prescription received from the patient's physician was for the synclara device.The patient stated he will discuss switching to the vest with his pulmonologist next week.The patient stated the synclara device is scheduled to be picked up from his home on (b)(6) 2022.No additional information was provided.Several attempts to obtain additional information from the patient's physician including a physician opinion on cause of the event was unsuccessful.The synclara cough system is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness.Instructions for use lists pulmonary barotrauma as a possible adverse condition that can occur when using the synclara cough system.Inspection of the device found two instances of error code 014 in the device therapy log: one instance occurred on (b)(6) 2022, and the second instance occurred on (b)(6)2022.On (b)(6) 2022, the average inhale pressure value was recorded at 20cmh2o, 5cmh2o above the 15cmh2o pressure set point but within range of prescribed therapy (inhaled pressure 10 to 50).A therapy was completed 2 minutes after error code 014 occurred.On (b)(6)2022, the average inhale pressure value was recorded at 27cmh2o, 12cmh2o above the 15cmh2o pressure set point but within range of prescribed therapy.Two therapies were completed within 4-5 minutes after error code 014 occurred (per the patient's prescribed therapy, treatment on the synclara was ordered 2-4 x per day).These occurrences both happened 20 seconds into the therapy.The timing indicates that the error occurred at the end of the fourth inhale phase of therapy.Error code 014 is triggered when measured values are 3 cmh2o above the set point.The device instructions for use state if error code 014 occurs, make sure the correct patient circuit is set up for the required therapy.Patients should also ensure all connections are tight prior to the start of therapy.The patient circuit returned with the device was not the circuit used on (b)(6) 2022 and (b)(6) 2022, as it had no uses on it.Therapy settings were a modified version of the low preset care plan.These settings, and the modified version of the medium and high preset care plans, were within the patient's prescription.The device ran low care plan therapy at the above settings without any issues.No pressure spikes were observed.The device passed end of line testing using calibrated equipment.Output flows and pressure were within specification.No problem was found with the function of the device.A pleural effusion is an accumulation of fluid between tissues that line the lungs and chest.A pneumothorax is a condition that occurs when air leaks into the space between the lungs and chest wall.Indications for chest tube drainage include pleural effusion and pneumothorax.Although there was no allegation of a device malfunction and the device functioned as intended, a use error cannot be ruled out as it was noted the patient completed two therapies in a short span of time and the patient circuit set up used during the recorded therapies was not returned to confirm the correct patient circuit was used and connections were secure.The reported event of a collapsed lung/pneumothorax and pleural effusion required medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Therefore, hillrom considers this a reportable serious injury.Based on this information, no further action is required.

• Brand Name: SYNCLARA, NON-FT SW,HC,NA
• Type of Device: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 13660061
• MDR Text Key: 286517739
• Report Number: 3008778542-2022-00001
• Device Sequence Number: 1
• Product Code: NHJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: M08575
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other